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Amvisc 0.8 Ml Syringe And Amvisc Plus, O.8 Ml Syringe

FDA PMA

Class III (US FDA PMA)

PMA P810025

by Bausch & Lomb, Inc.

Identity

Trade Name
AMVISC(R) FDA PMA
Generic Name
AID, SURGICAL, VISCOELASTIC FDA PMA

Identifiers

PMA Number
P810025 FDA PMA
FDA Product Code
LZP FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 886.4275 FDA PMA
Regulation Number
886.4275 FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APPR Approved FDA PMA

AMVISC 0.8 ML Syringe and AMVISC Plus, 0.8 ML Syringe is an Aid, Surgical, Viscoelastic device used in ophthalmic surgery. It is a sterile, single-use viscoelastic solution supplied in a pre-filled syringe for intraocular use during cataract and other anterior segment procedures.

The device is manufactured by Bausch & Lomb, Inc. and supplied as a sterile, single-use syringe containing 0.8 mL of viscoelastic agent. It is intended for use in ophthalmic surgical settings and is authorized under FDA Premarket Approval (PMA) number P810025, with product code LZP and classification under regulation 886.4275.

Frequently asked questions

What is the AMVISC 0.8 ML Syringe used for?

The AMVISC 0.8 ML Syringe is an Aid, Surgical, Viscoelastic device used in ophthalmic surgery. It is specifically designed for intraocular use during procedures such as cataract surgery to maintain anterior chamber depth, protect corneal endothelium, and manipulate tissues.

Is the AMVISC 0.8 ML Syringe sterile and single-use?

Yes, the AMVISC 0.8 ML Syringe is supplied as a sterile, single-use device. It contains 0.8 mL of viscoelastic solution in a pre-filled syringe and is intended for one-time use during ophthalmic surgical procedures.

What regulatory authorization does the AMVISC 0.8 ML Syringe have?

The AMVISC 0.8 ML Syringe is authorized under FDA Premarket Approval (PMA) with PMA number P810025. It is classified as a Class III device under regulation number 886.4275 and product code LZP.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA PMA P810025 24 fields · synced Sep 18, 2026